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Trang Nguyen1,2, Kirsten Holdt Henningsen1, Jamie C Brehaut1,2, Erica Hoe1, Kumanan Wilson1,3 1Clinical Epidemiology Program, Ottawa Hospital Research Institute; 2Epidemiology and Community Medicine, University of Ottawa; 3Department of Medicine, University of Ottawa, Ottawa, Canada Introduction: The effectiveness of pandemic vaccine campaigns such as the H1N1 vaccine rollout is dependent on both the vaccines’ effectiveness and the general public’s willingness to be vaccinated. It is therefore critical to understand the factors that influence the decision of members of the public whether to get vaccinated with new, emergently released vaccines. Methods: A systematic review of English language quantitative surveys was conducted to identify consistent predictors of the decision to accept or decline any (pre)pandemic vaccine, including the H1N1 influenza A vaccine. A total of ten studies were included in this review and all pertained to the 2009 H1N1 influenza A pandemic. Respondents’ willingness to receive a pandemic vaccine ranged from 8%–67% across the ten studies. The factors reported to be consistent predictors of the intention to vaccinate were: risk of infection, proximity or severity of the public health event, severity of personal consequences resulting from the illness, harm or adverse events from the vaccine, acceptance of previous vaccination, and ethnicity. Age and sex were the demographic variables examined most frequently across the ten studies and there was no consistent association between these variables and the intention to accept or reject a pandemic vaccine. Conclusion: Some predictors of the intention to accept or decline a (pre)pandemic vaccine or the H1N1 influenza A vaccine are consistently identified by surveys. Understanding the important factors influencing the acceptance of a pandemic vaccine by individual members of the public may help inform strategies to improve vaccine uptake during future pandemics. Keywords: pandemic, H1N1 influenza A, emergent vaccine, personal risk, demographic

Purpose. Children with neurodevelopmental disorders (Neuro) pose complex parenting challenges, particularly if the condition co-occurs with behaviour problems. Such challenges are likely to impact caregiver health and well-being. This study explores the extent to which caregivers of children with both 'Neuro' and behaviour problems differ in their physical and psychosocial outcomes from caregivers of children with either condition or neither condition. Method. The first wave of data collected in the National Longitudinal Survey of Children and Youth in Canada (1994) was used to identify four groups of caregivers of 4 to 11-year-old children: caregivers of children with a 'Neuro' disorder and externalising behaviour problems (Both; n = 414), caregivers of children with a 'Neuro' disorder only (Neuro Only; n = 750), caregivers of children with an externalising behaviour problem only (Ext Only; n = 1067), and caregivers of children with neither health condition (Neither; n = 7236). Results. Caregivers in the 'Both' group were least likely to report excellent or very good health, and more frequently reported chronic conditions such as asthma, arthritis, back problems, migraine headaches, and limitations in activities as compared to the 'Neither' group. This group also exhibited higher depression scores, experienced more problematic family functioning, and reported lower social support than the 'Neither' group. Scores for caregivers in the 'Ext Only' and 'Neuro Only' groups tended to lie between the 'Both' and 'Neither' group scores and often did not differ from one another. Conclusions. Caregivers of children with both neurodevelopmental disorders and behaviour problems exhibited a greater number of health and psychosocial problems. While addressing children's behaviour problems, health care professionals should also consider caregiver physical and psychosocial health as this may also have an impact on children's well-being. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To examine selected medical services for children treated for attention-deficit/hyperactivity disorder (ADHD) in a general population setting with universal health insurance. DESIGN: Retrospective analysis of administrative prescription and health services databases spanning from 1990 to 1996. SETTING: British Columbia, Canada. PATIENTS: Children (<19 years of age) who had received the psychostimulant methylphenidate (MPH; Ritalin) on a chronic basis (chronic-MPH group), who had received MPH on any other basis (nonchronic-MPH group), and who were in a no-MPH comparison group. MAIN OUTCOME MEASURES: The number of individuals who received any of the following services based on claims submitted by qualified practitioners: 1) emergency care, 2) critical care, 3) injury-related diagnostic and treatment services, 4) complementary and alternative medical (CAM) care, and 5) other diagnostic and treatment services (audiometry and allergy testing). RESULTS: Prevalence of services users was higher among MPH-treated than nontreated children for all types of services (except critical care services in the chronic-MPH group) after adjusting for effects of age, sex, socioeconomic status, and geographic setting, with odds ratios ranging from 1.49 to 3.17. There were no differences between the 2 MPH-treated groups. CONCLUSIONS: Children treated with MPH for ADHD or presumed ADHD are more frequent users of a wide range of medical services than are other children. Findings support and extend existing evidence of increased use of medical services by this population of children. Findings have implications for service planning, including injury prevention, with these children. High utilization of audiometric, allergy, and CAM services warrants further scrutiny. [ABSTRACT FROM AUTHOR]

Background: There is compelling evidence of an inverse relationship between level of education and increased mortality. In contrast to this, one study showed that among subjects with Alzheimer's Disease, those with high education are more than twice as likely to die earlier; however, this result has proven difficult to replicate. We examine the relationship between education and mortality by cognitive status, using a large, nationally representative sample of elderly people.Patients: A representative sample of 10,263 people, aged 65 or over, from the 10 Canadian provinces, participated in the Canadian Study of Health and Aging in 1991.Methods: Information about age, gender, education, and an initial screening for cognitive impairment were collected; those who screened positive for cognitive impairment were referred for a complete clinical and neuropsychological examination, from which cognitive status and clinical severity of dementia were assessed. Vital status and date of death were collected at follow-up in 1996. The analysis was conducted using survival analysis.Results: Cognitive status modifies the relationship between education and mortality. For those with no cognitive impairment, an inverse relationship between education and mortality exists. Elderly people with cognitive impairment but no dementia, or those with dementia, are more likely to die early than the cognitively normal at baseline, but no relationship exists between education and mortality.Interpretation: These findings do not support previous work that showed a higher risk of mortality among highly educated dementia subjects. [ABSTRACT FROM AUTHOR]

BACKGROUND: As patients become more involved in health care decisions, there may be greater opportunity for decision regret. The authors could not find a validated, reliable tool for measuring regret after health care decisions. METHODS: A 5-item scale was administered to 4 patient groups making different health care decisions. Convergent validity was determined by examining the scale's correlation with satisfaction measures, decisional conflict, and health outcome measures. RESULTS: The scale showed good internal consistency (Cronbach's alpha = 0.81 to 0.92). It correlated strongly with decision satisfaction (r = -0.40 to -0.60), decisional conflict (r = 0.31 to 0.52), and overall rated quality of life (r = -0.25 to -0.27). Groups differing on feelings about a decision also differed on rated regret: F(2, 190) = 31.1, P < 0.001. Regret was greater among those who changed their decisions than those who did not, t(175) = 16.11, P < 0.001. CONCLUSIONS: The scale is a useful indicator of health care decision regret at a given point in time. [ABSTRACT FROM AUTHOR]

BACKGROUND: Caring for any child involves considerable resources, but the demands for these resources are often increased when caring for a child with a disability. These demands have implications for the psychologic and physical health of the caregiver (CG). Although a number of recent trends in health care stress the importance of studying and promoting the health of CGs of children with disabilities, the literature in this area exhibits 2 major weaknesses, ie, most studies draw conclusions from relatively small, potentially biased, clinic-based samples and the majority of work has focused on the psychologic health of CGs, whereas little research has been undertaken to study their physical well-being. The goal of this study was to compare the physical and psychologic health of CGs of children with cerebral palsy (CP) with that of the general population of CGs. METHODS: Data on the physical and psychologic health of 468 primary CGs of children with CP, drawn from 18 of 19 publicly funded children's rehabilitation centers in Ontario, Canada, were collected with a self-completed questionnaire and a face-to-face interview. Identical items and scales had been administered previously to nationally representative samples of the Canadian population in 2 large-scale Canadian surveys, ie, the National Population Health Survey (NPHS) and the National Longitudinal Study of Children and Youth (NLSCY). Subsamples of those data, restricted to adult residents of the province of Ontario who were parents, allowed a comparison of our sample of CGs of children with CP with parent samples from both the NLSCY (n = 2414) and the NPHS (n = 5549). OUTCOME MEASURES: Demographic variables included CG age, gender, education, income, and work-related variables. Psychologic health and support variables included social support, family functioning, frequency of contacts, distress, and emotional and cognitive problems. Physical health variables included the number and variety of chronic conditions, vision, hearing, and mobility problems, and experience of pain. RESULTS: CGs of children with CP had lower incomes than did the general population of CGs (proportion with income over 60,000 dollars: CG: 40.9%; NLSCY: 51.4%), despite the absence of any important differences in education between the 2 samples. Results showed that CGs of children with CP were less likely to report working for pay (CG: 66%; NLSCY: 81.2%), less likely to be engaged in full-time work (CG: 67.5%; NLSCY: 73.2%), and more likely to list caring for their families as their main activity (CG: 37.2%; NLSCY: 28.4%). Measures of support showed no difference in reported social support (CG: mean score: 14.5; SD: 3.4; NLSCY: mean score: 14.3; SD: 2.7) or family functioning (CG: mean score: 8.6; SD: 5.6; NLSCY: mean score: 9.0; SD: 4.9) between the 2 samples, although the CG sample did report a statistically greater number of support contacts (CG: mean score: 4.5; SD: 0.7; NPHS: mean score: 4.2; SD: 0.9). Measures of psychologic health showed greater reported distress (CG: mean score: 4.7; SD: 4.4; NPHS: mean score: 2.2; SD: 2.7), chronicity of distress (CG: mean score: 5.5; SD: 1.4; NPHS: mean score: 5.2; SD: 1.1), emotional problems (CG: 25.3% indicating problems; NPHS: 13.7%), and cognitive problems (CG: 38.8%; NPHS: 14.3%) among CGs of children with CP. They also reported a greater likelihood of a variety of physical problems, including back problems (CG: 35.5% reporting the condition; SE: 2.2%; NLSCY: 12.2%; SE: 0.7%), migraine headaches (CG: 24.2%; SE: 2.0%; NLSCY: 11.2%; SE: 0.7%), stomach/intestinal ulcers (CG: 8.4%; SE: 1.3%; NLSCY: 1.7%; SE: 0.3%), asthma (CG: 15.8%; SE: 1.7%; NLSCY: 6.3%; SE: 0.5%), arthritis/rheumatism (CG: 17.3%; SE: 1.8%; NLSCY: 7.3%; SE: 0.5%), and experience of pain (CG: 28.8%; SE: 2.1%; NPHS: 11.0%; SE: 0.5), as well as a greater overall number of chronic physical conditions (CG: 24.1% reporting no chronic conditions; NLSCY: 55.2%). CONCLUSIONS: Although many families cope well despite the added challenges of caring for a child with a disability, our findings suggest that the demands of their children's disabilities can explain differences in the health status of parents and that parents of children with CP are more likely to have a variety of physical and psychologic health problems. Many of these findings are consistent with a stress process model, in which stress from caregiving can directly or indirectly affect a variety of measures of health, although some of the findings (asthma and arthritis) seem to strain this hypothesis. Alternate interpretations of these findings include the possibility that parents who are in regular contact with the health care system may have more opportunities to discuss and receive attention for their own health concerns than do comparison adults or that the greater number of health issues reported by CGs is related to the nature of our study, perhaps leading these parents to focus on their health and well-being in more depth than is usually feasible in a population survey. CGs of children with CP also had lower incomes, despite the absence of any important differences in education. The findings are consistent with the idea that the financial burden of caring for a child with a disability results in part from a reduced availability of these parents to work for pay. IMPLICATIONS FOR SERVICE PROVIDERS: Physicians and other health care professionals should be aware of the important relationship between child disability and CG health. Family-centered policies and services that explicitly consider CG health are likely to benefit the well-being of both CGs and their families. Future work should address the extent to which the family-centeredness of services, as experienced by CGs, is associated with better health outcomes for parents and their families. [ABSTRACT FROM AUTHOR]

Misinformation hinders the impact of public health initiatives. Efforts to counter misinformation likely do not consider the full range of factors known to affect how individuals make decisions and act on them. Implementation science tools and concepts can facilitate the development of more effective interventions against health misinformation by leveraging advances in behavior specification, uptake of evidence, and theory-guided development and evaluation of complex interventions. We conducted a scoping review of misinformation literature reviews to document whether and how important concepts from implementation science have already informed the study of misinformation. Of 90 included reviews, the most frequently identified implementation science concepts were consideration of mechanisms driving misinformation (78%) and ways to intervene on, reduce, avoid, or circumvent it (71%). Other implementation science concepts were discussed much less frequently, such as tailoring strategies to the relevant context (9%) or public involvement in intervention development (9%). Less than half of reviews (47%) were guided by any theory, model, or framework. Among the 26 reviews that cited existing theories, most used theory narratively (62%) or only mentioned/cited the theory (19%), rather than using theory explicitly to interpret results (15%) or to inform data extraction (12%). Despite considerable research and many summaries of how to intervene against health misinformation, there has been relatively little consideration of many important advances in the science of health care implementation. This review identifies key areas from implementation science that might be useful to support future research into designing effective misinformation interventions., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Importance: Extubation Advisor (EA) is a novel software tool that generates a synoptic report for each Spontaneous Breathing Trial (SBT) conducted to inform extubation decision-making., Objectives: To assess bedside EA implementation, perceptions of utility, and identify barriers and facilitators of use., Design, Setting and Participants: We conducted a phase I mixed-methods interventional study in three mixed intensive care unit (ICUs) in two academic hospitals. We interviewed critical care physicians (MDs) and respiratory therapists (RTs) regarding user-centered design principles and usability., Analysis: We evaluated our ability to consent participants (feasibility threshold 50%), capture complete data (threshold 90%), generate and review EA reports in real-time (thresholds 75% and 80%, respectively), and MD perception of tool usefulness (6-point Likert scale). We analyzed interview transcripts using inductive coding to identify facilitators and barriers to EA implementation and perceived benefit of tool use., Results: We enrolled 31 patients who underwent 70 SBTs. Although consent rates [31/31 (100%], complete data capture [68/68 (100%)], and EA report generation [68/70 (97.1%)] exceeded feasibility thresholds, reports were reviewed by MDs for [55/70 (78.6%)] SBTs. Mean MD usefulness score was 4.0/6. Based on feedback obtained from 36 interviews (15 MDs, 21 RTs), we revised the EA report twice and identified facilitators (ability to track patient progress, enhance extubation decision-making, and provide support in resource-limited settings) and barriers (resource constraints, need for education) to tool implementation. Half of respondents (9 MDs, 9 RTs; combined 50%) perceived definite or potential benefit to EA tool use., Conclusion: This is the first study of a waveform-based variability-derived, predictive clinical decision support tool evaluated in adult ICUs. Our findings support the feasibility of integrating the EA tool into bedside workflow. Clinical trials are needed to assess the utility of the EA tool in practice and its impact on extubation decision-making and outcomes., Trial Registration: NCT04708509., Competing Interests: Declaration of Conflicting InterestsDr A Seely and Dr C Herry are named on a patent related to Extubation Advisor technology described in this paper. Dr Seely is founder and board chairman of Therapeutic Monitoring Systems, a company founded to help research, develop, and commercialize clinical decision support tools based on variability analysis, including Extubation Advisor.

Objectives: Lab testing is a high-volume activity that is often overused, leading to wasted resources and inappropriate care. Improving test ordering practices in tertiary care involves deciding where to focus scarce intervention resources, but clear guidance on how to optimize these resources is lacking. We aimed to explore context-sensitive factors and processes that inform individual decisions about laboratory stewardship interventions by speaking to key interest holders in this area., Methods: We conducted semi-structured interviews with test-ordering intervention development experts and authors of test-ordering guidance documents to explore five broad topics: 1) processes used to prioritize tests for intervention; 2) factors considered when deciding which tests to target; 3) measurement of these factors; 4) interventions selected; 5) suggestions for a framework to support these decisions. Transcripts were double coded using directed-content and thematic analysis., Results: We interviewed 14 intervention development experts. Experts noted they frequently consider test volume, test value, and patient care when deciding on a test to target. Experts indicated that quantifying many relevant factors was challenging. Processes to support these decisions often involved examining local data, obtaining buy-in, and relying on an existing guideline. Suggestions for building a framework emphasized the importance of collaboration, consideration of context and resources, and starting with "easy wins" to gain support and experience., Conclusions: Our study provides insight into the factors and processes experts consider when deciding which tests to target for intervention and can inform the development of a framework to guide the selection of tests for intervention and guideline development., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

Background: Recruiting participants to clinical trials is an ongoing challenge, and relatively little is known about what recruitment strategies lead to better recruitment. Recruitment interventions can be considered complex interventions, often involving multiple components, targeting a variety of groups, and tailoring to different groups. We used the Template for Intervention Description and Replication (TIDieR) reporting checklist (which comprises 12 items recommended for reporting complex interventions) to guide the assessment of how recruitment interventions are described. We aimed to (1) examine to what extent we could identify information about each TIDieR item within recruitment intervention studies, and (2) observe additional detail for each item to describe useful variation among these studies., Methods: We identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items., Results: We assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%)., Conclusions: Our TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions., (© 2024. The Author(s).)

Background: The route into the body for many pathogens is through the eyes, nose and mouth (i.e., the 'T-zone') via inhalation or fomite-based transfer during face touching. It is important to understand factors that are associated with touching the T-zone to inform preventive strategies., Purpose: To identify theory-informed predictors of intention to reduce facial 'T-zone' touching and self-reported 'T-zone' touching., Methods: We conducted a nationally representative prospective questionnaire study of Canadians. Respondents were randomized to answer questions about touching their eyes, nose, or mouth with a questionnaire assessing 11 factors from an augmented Health Action Process Approach at baseline: intention, outcome expectancies, risk perception, individual severity, self-efficacy, action planning, coping planning, social support, automaticity, goal facilitation and stability of context. At 2-week follow-up, we assessed HAPA-based indicators of self-regulatory activities (awareness of standards, effort, self-monitoring) and self-reported behaviour (primary dependent variable)., Results: Of 656 Canadian adults recruited, 569 responded to follow-up (87% response rate). Across all areas of the 'T-zone', outcome expectancy was the strongest predictor of intention to reduce facial 'T-zone' touching, while self-efficacy was a significant predictor for only the eyes and mouth. Automaticity was the strongest predictor of behaviour at the 2-week follow-up. No sociodemographic or psychological factors predicted behaviour, with the exception of self-efficacy, which negatively predicted eye touching., Conclusion: Findings suggest that focusing on reflective processes may increase intention to reduce 'T-zone' touching, while reducing actual 'T-zone' touching may require strategies that address the automatic nature of this behaviour., (© 2023 The Authors. British Journal of Health Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.)

Background: There are few data on patient and public involvement (PPI) in pragmatic trials. We aimed to describe the prevalence and nature of PPI within pragmatic trials, describe variation in prevalence of PPI by trial characteristics and compare prevalence of PPI reported by trial authors to that reported in trial publications., Methods: We applied a search filter to identify pragmatic trials published from 2014 to 2019 in MEDLINE. We invited the corresponding authors of pragmatic trials to participate in an online survey about their specific trial., Results: Of 3163 authors invited, 2585 invitations were delivered, 710 (27.5%) reported on 710 unique trials and completed the survey; 334 (47.0%) conducted PPI. Among those who conducted PPI, for many the aim was to increase the research relevance (86.3%) or quality (76.5%). Most PPI partners were engaged at protocol development stages (79.1%) and contributed to the co-design of interventions (70.9%) or recruitment or retention strategies (60.5%). Patient and public involvement was more common among trials involving children, trials conducted in the United Kingdom, cluster randomized trials, those explicitly labelled as "pragmatic" in the study manuscript, and more recent trials. Less than one-quarter of trials (22.8%) that reported PPI in the survey also reported PPI in the trial manuscript., Interpretation: Nearly half of trialists in this survey reported conducting PPI and listed several benefits of doing so, but researchers who did not conduct PPI often cited a lack of requirement for it. Patient and public involvement appears to be significantly underreported in trial publications. Consistent and standardized reporting is needed to promote transparency about PPI methods, outcomes, challenges and benefits., Competing Interests: Competing interests: Charles Weijer reports receiving consulting fees from Cardialen and Eli Lilly & Company. Shelley Vanderhout reports receiving a Postdoctoral Fellowship Award and a System Impact Fellowship Award from the Canadian Institutes of Health Research (in support of the current manuscript). Anne Spinewine reports receiving a Mobility Grant from Fondation Mont-Godinne. No other competing interests were declared., (© 2023 CMA Impact Inc. or its licensors.)

Background: Wide variations in emergency department (ED) syncope management exist. The Canadian Syncope Risk Score (CSRS) was developed to predict the probability of 30-day serious outcomes after ED disposition. Study objectives were to evaluate the acceptability of proposed CSRS practice recommendations among providers and patients, and identify barriers and facilitators for CSRS use to guide disposition decisions., Methods: We conducted semi-structured interviews with 41 physicians involved in ED syncope and 35 ED patients with syncope. We used purposive sampling to ensure a variety of physician specialties and CSRS patient risk levels. Thematic analysis was completed by two independent coders with consensus meetings to resolve conflicts. Analysis proceeded in parallel with interviews until data saturation., Results: The majority (97.6%; 40/41) of physicians agreed with discharge of low risk (CSRS ≤ 0) but opined that 'no follow up' changed to 'follow-up as needed'. Physicians indicated current practices do not align with the medium-risk recommendation to discharge patients with 15-day monitoring (CSRS = 1-3; due to lack of access to monitors and timely follow-up) and the high-risk recommendation (CSRS ≥ 4) to potentially discharge patients with 15-day monitoring. Physicians recommended brief hospitalization of high-risk patients due to patient safety concerns. Facilitators included the CSRS-based patient education and scores supporting their clinical gestalt. Patients reported receiving varying levels of information regarding syncope and post-ED care, were satisfied with care received and preferred less resource intensive options., Conclusion: Our recommendations based on the study results were: discharge of low-risk patients with physician follow-up as needed; discharge of medium-risk patients with 15-day cardiac monitoring and brief hospitalization of high-risk patients with 15-day cardiac monitoring if discharged. Patients preferred less resource intensive options, in line with CSRS recommended care. Implementation should leverage identified facilitators (e.g., patient education) and address the barriers (e.g., monitor access) to improve ED syncope care., (© 2023. The Author(s), under exclusive licence to Canadian Association of Emergency Physicians (CAEP)/ Association Canadienne de Médecine d'Urgence (ACMU).)

Use of rigorous study design methods and transparent reporting in publications are 2 key strategies proposed to improve the reproducibility of preclinical research. Despite promotion of these practices by funders and journals, assessments suggest uptake is low in preclinical research. Thirty preclinical scientists were interviewed to better understand barriers and enablers to rigorous design and reporting. The interview guide was informed by the Theoretical Domains Framework, which is a framework used to understand determinants of current and desired behavior. Four global themes were identified; 2 reflecting enablers and 2 reflecting barriers. We found that basic scientists are highly motivated to apply the methods of rigorous design and reporting and perceive a number of benefits to their adoption (e.g., improved quality and reliability). However, there was varied awareness of the guidelines and in implementation of these practices. Researchers also noted that these guidelines can result in disadvantages, such as increased sample sizes, expenses, time, and can require several personnel to operationalize. Most researchers expressed additional resources such as personnel and education/training would better enable the application of some methods. Using existing guidance (Behaviour Change Wheel (BCW); Expert Recommendations for Implementing Change (ERIC) project implementation strategies), we mapped and coded our interview findings to identify potential interventions, policies, and implementation strategies to improve routine use of the guidelines by preclinical scientists. These findings will help inform specific strategies that may guide the development of programs and resources to improve experimental design and transparent reporting in preclinical research., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Lalu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Some laboratory testing practices may be of low value, leading to wasted resources and potential patient harm. Our scoping review investigated factors and processes that developers report using to inform decisions about what tests to target for practice improvement., Methods: We searched Medline on May 30th, 2019 and June 28th, 2021 and included guidelines, recommendation statements, or empirical studies related to test ordering practices. Studies were included if they were conducted in a tertiary care setting, reported making a choice about a specific test requiring intervention, and reported at least one factor informing that choice. We extracted descriptive details, tests chosen, processes used to make the choice, and factors guiding test choice., Results: From 114 eligible studies, we identified 30 factors related to test choice including clinical value, cost, prevalence of test, quality of test, and actionability of test results. We identified nine different processes used to inform decisions regarding where to spend intervention resources., Conclusions: Intervention developers face difficult choices when deciding where to put scarce resources intended to improve test utilization. Factors and processes identified here can be used to inform a framework to help intervention developers make choices relevant to improving testing practices., (© 2022 Walter de Gruyter GmbH, Berlin/Boston.)

Objectives: To describe prevalence of multiple primary outcomes, changes in primary outcomes and target sample sizes between protocols and final reports, and how issues of multiplicity are addressed in pragmatic trials., Study Design and Setting: Individually randomized trials labeled as pragmatic, published 2014-2019 in MEDLINE and registered with ClinicalTrials.gov., Results: We identified 262 final reports and located protocols for 159 (61%); primary outcomes were clearly reported in 145 (91%) protocols and 256 (98%) final reports. Thirty (19%) protocols and 38 (15%) final reports had multiple primary outcomes. Primary outcomes were present and identical in 128 (81%) matched protocol-final reports. Among 140 pairs with target sample sizes reported, 28 (20.0%) reduced their target sample size (mean 543 fewer participants per trial) and 16 (11.4%) increased it (mean 192 more participants per trial). Thirteen (29.5%) provided an explanation. Only 2 of 30 (7%) protocols and 4 of 38 (11%) final reports with co-primary outcomes explained how results would be interpreted in light of multiplicity; 21 of 30 (70%) protocols and 20 of 38 (53%) final reports accounted for co-primary outcomes in power calculations., Conclusion: Co-primary outcomes are common in pragmatic trials; improved transparency around design and analysis decisions involving co-primary outcomes is required., (Copyright © 2021. Published by Elsevier Inc.)

Background: Under-recruitment regularly impedes clinical trials, leading to wasted resources and opportunity costs. Methods for designing trial participation strategies rarely consider behavior change theory., Objective: Informed by the Theoretical Domains Framework, we identified factors important to participating in Huntington's disease research and provide examples of how such a theory-informed approach can make specific suggestions about how to design targeted recruitment strategies., Methods: We identified a range of trial participation barriers and enablers based on interviews of key informants and implemented an online survey of members of the Huntington's disease community, asking them to rate the extent to which different factors would affect likelihood to participate in a generic Huntington's disease trial., Results: From 4,195 members, we received 323 responses and 243 completed surveys (323/4,195 or 8% participation, 243/323 or 75% completion). Respondents endorsed 9 barriers and 23 enablers relevant to trial participation. Most frequently endorsed barriers were travel to the study site (69%), worry about unknown side effects (65%), trial documents being difficult to understand (64%), and participation affecting other activities (49%). Enablers included optimism about likelihood of trial participation leading to a cure (98%), helping others (98%), contributing to science (97%), and having helpful people available to help with the participation decision (89%)., Conclusion: Our theory-informed survey to identify barriers to and enablers of Huntington's disease trial participation identified 32 factors, from 13 theoretical domains relevant to trial participation, and suggests effective approaches for improving trial participation and patient experience.

Objectives: To describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent., Methods: Survey of primary trial reports, published 2014-2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov., Results: Among 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001)., Discussion: Not obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public's trust in research., Competing Interests: Competing interests: CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. Other authors report no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Objective: Feasibility studies are increasingly being used to support the development of, and investigate uncertainties around, future large-scale trials. The future trial can be designed with either a pragmatic or explanatory mindset. Whereas pragmatic trials aim to inform the choice between different care options and thus, are designed to resemble conditions outside of a clinical trial environment, explanatory trials examine the benefit of a treatment under more controlled conditions. There is existing guidance for designing feasibility studies, but none that explicitly considers the goals of pragmatic designs. We aimed to identify unique areas of uncertainty that are relevant to planning a pragmatic trial., Results: We identified ten relevant domains, partly based on the pragmatic-explanatory continuum indicator summary-2 (PRECIS-2) framework, and describe potential questions of uncertainty within each: intervention development, research ethics, participant identification and eligibility, recruitment of individuals, setting, organization, flexibility of delivery, flexibility of adherence, follow-up, and importance of primary outcome to patients and decision-makers. We present examples to illustrate how uncertainty in these domains might be addressed within a feasibility study., Conclusion: Researchers planning a feasibility study in advance of a pragmatic trial should consider feasibility objectives specifically relevant to areas of uncertainty for pragmatic trials., (Copyright © 2021. Published by Elsevier Inc.)

In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention-not the unit of randomisation-that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT., Competing Interests: Competing interests: CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. CW, JCB, DF and MT are authors of the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: We established a large database of trials to serve as a resource for future methodological and ethical analyses. Here, we use meta-data to describe the broad landscape of pragmatic trials including research areas, identification as pragmatic, quality of trial registry data and enrolment., Study Design and Setting: Trials were identified by a validated search filter and included if a primary report of a health-related randomized trial published January 2014-April 2019. Data were collated from MEDLINE, Web of Science, ClinicalTrials.gov, and full text., Results: 4337 eligible trials were identified from 13,065 records, of which 1988 were registered in ClinicalTrials.gov. Research areas were diverse, with the most common being general and internal medicine; public, environmental and occupational health; and health care sciences and services. The term "pragmatic" was seldom used in titles or abstracts. Several domains in ClinicalTrials.gov had questionable data quality. We estimated that one-fifth of trials under-accrued by at least 15%., Conclusion: There is a need to improve reporting of pragmatic trials and quality of trial registry data. Under accrual remains a challenge in pragmatic RCTs despite calls for more streamlined recruitment approaches. The diversity of pragmatic trials should be reflected in future ethical analyses., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Healthcare Audit and Feedback (A&F) interventions have been shown to be an effective means of changing healthcare professional behavior, but work is required to optimize them, as evidence suggests that A&F interventions are not improving over time. Recent published guidance has suggested an initial set of best practices that may help to increase intervention effectiveness, which focus on the "Nature of the desired action," "Nature of the data available for feedback," "Feedback display," and "Delivering the feedback intervention." We aimed to develop a generalizable evaluation tool that can be used to assess whether A&F interventions conform to these suggestions for best practice and conducted initial testing of the tool through application to a sample of critical care A&F interventions., Methods: We used a consensus-based approach to develop an evaluation tool from published guidance and subsequently applied the tool to conduct a secondary analysis of A&F interventions. To start, the 15 suggestions for improved feedback interventions published by Brehaut et al. were deconstructed into rateable items. Items were developed through iterative consensus meetings among researchers. These items were then piloted on 12 A&F studies (two reviewers met for consensus each time after independently applying the tool to four A&F intervention studies). After each consensus meeting, items were modified to improve clarity and specificity, and to help increase the reliability between coders. We then assessed the conformity to best practices of 17 critical care A&F interventions, sourced from a systematic review of A&F interventions on provider ordering of laboratory tests and transfusions in the critical care setting. Data for each criteria item was extracted by one coder and confirmed by a second; results were then aggregated and presented graphically or in a table and described narratively., Results: In total, 52 criteria items were developed (38 ratable items and 14 descriptive items). Eight studies targeted lab test ordering behaviors, and 10 studies targeted blood transfusion ordering. Items focused on specifying the "Nature of the Desired Action" were adhered to most commonly-feedback was often presented in the context of an external priority (13/17), showed or described a discrepancy in performance (14/17), and in all cases it was reasonable for the recipients to be responsible for the change in behavior (17/17). Items focused on the "Nature of the Data Available for Feedback" were adhered to less often-only some interventions provided individual (5/17) or patient-level data (5/17), and few included aspirational comparators (2/17), or justifications for specificity of feedback (4/17), choice of comparator (0/9) or the interval between reports (3/13). Items focused on the "Nature of the Feedback Display" were reported poorly-just under half of interventions reported providing feedback in more than one way (8/17) and interventions rarely included pilot-testing of the feedback (1/17 unclear) or presentation of a visual display and summary message in close proximity of each other (1/13). Items focused on "Delivering the Feedback Intervention" were also poorly reported-feedback rarely reported use of barrier/enabler assessments (0/17), involved target members in the development of the feedback (0/17), or involved explicit design to be received and discussed in a social context (3/17); however, most interventions clearly indicated who was providing the feedback (11/17), involved a facilitator (8/12) or involved engaging in self-assessment around the target behavior prior to receipt of feedback (12/17)., Conclusions: Many of the theory-informed best practice items were not consistently applied in critical care and can suggest clear ways to improve interventions. Standardized reporting of detailed intervention descriptions and feedback templates may also help to further advance research in this field. The 52-item tool can serve as a basis for reliably assessing concordance with best practice guidance in existing A&F interventions trialed in other healthcare settings, and could be used to inform future A&F intervention development., Trial Registration: Not applicable., (© 2021. The Author(s).)

Background: Cluster randomized trials (CRTs) are trials in which intact groups such as hemodialysis centers or shifts are randomized to treatment or control arms. Pragmatic CRTs have been promoted as a promising trial design for nephrology research yet may also pose ethical challenges. While randomization occurs at the cluster level, the intervention and data collection may vary in a CRT, challenging the identification of research participants. Moreover, when a waiver of patient consent is granted by a research ethics committee, there is an open question as to whether and to what degree patients should be notified about ongoing research or be provided with a debrief regarding the nature and results of the trial upon completion. While empirical and conceptual research exploring ethical issues in pragmatic CRTs has begun to emerge, there has been limited discussion with patients, families, or caregivers of patients undergoing hemodialysis., Objective: To explore with patients and families with experience of hemodialysis research the challenges raised by different approaches to designing pragmatic CRTs in hemodialysis. Specifically, their perceptions of (1) the use of a waiver of consent, (2) notification processes and information provided to participants, and (3) any other concerns about cluster randomized designs in hemodialysis., Design: Focus group and interview discussions of hypothetical clinical trial designs., Setting: Focus groups and interviews were conducted in-person or via videoconference or telephone., Participants: Patient partners in hemodialysis research, defined as patients with personal experience of dialysis or a family member who had experience supporting a patient receiving hemodialysis, who have been actively involved in discussions to advise a research team on the design, conduct, or implementation of a hemodialysis trial., Methods: Participants were invited to participate in focus groups or individual discussions that were audio recorded with consent. Recorded interviews were transcribed verbatim prior to analysis. Transcripts were analyzed using a thematic analysis approach., Results: Two focus groups, three individual interviews, and one interview involving a patient and family member were conducted with 17 individuals between February 2019 and May 2020. Participants expressed support for approaches that emphasized patient choice. Disclosure of patient-relevant risks and information were key themes. Both consent and notification processes served to generate trust, but bypassing patient choice was perceived as undermining this trust. Participants did not dismiss the option of a waiver of consent. They were, however, more restrictive in their views about when a waiver of consent may be acceptable. Patient partners were skeptical of claims to impracticability based on costs or the time commitments for staff., Limitations: All participants were from Canada and had been involved in the design or conduct of a trial, limiting the degree to which results may be extrapolated., Conclusions: Given the preferences of participants to be afforded the opportunity to decide about trial participation, we argue that investigators should thoroughly investigate approaches that allow participants to make an informed choice regarding trial participation. In keeping with the preference for autonomous choice, there remains a need to further explore how consent approaches can be designed to facilitate clinical trial conduct while meeting their ethical requirements. Finally, further work is needed to define the limited circumstances in which waivers of consent are appropriate., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: C.W. receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute (RTI) International., (© The Author(s) 2021.)

Background: Ensuring adequate, informed, and timely participation in clinical trials is a multifactorial problem. We have previously developed a systematic, tailorable survey development approach that is informed by theory, can identify barriers and enablers to participation, and can suggest recruitment strategies to address these issues. In this study, we surveyed subscribers to the Canadian Breast Cancer Network (CBCN) in order to identify a comprehensive list of theory-informed barriers and enablers relevant to participation in a hypothetical breast cancer trial., Methods: We developed and conducted an online survey of breast cancer patients informed by the Theoretical Domains Framework and designed to determine previous experience with clinical trials, knowledge about clinical trials, and importance of a comprehensive list of barriers and enablers to trial participation. Participants were contacted by email or through social media., Results: From 2451 subscribers of the CBCN, we received 244 responses and 210 completed surveys (244/2451 or 9.9% participation, 210/244 or 86.1% completion). A total of 38% of respondents indicated experience in trial participation, but 83% indicated confidence in their knowledge about clinical trials. Those who had previously participated in clinical trials were more confident in their knowledge (χ 2 = 6.77, p = 0.009) and answered more knowledge questions (t = -3.90 p = 0.000). Endorsed barriers and enablers to participation included 39 factors across 12 of 14 domains relevant to behaviour change. Our approach identifies barriers that might be meaningfully addressed by careful knowledge provision (' If I would learn more about my condition'; 'If I find the trial documents hard to understand '), those that may require other theory-informed approaches to address (' my feelings about the quality of my drug plan '; ' my worry over unknown side effects '), and those that may require tailored approaches depending on participant differences such as previous experience in trials (' If there were patient-friendly decision-making tools to help you make your participation decision ')., Discussion: This work demonstrates that a comprehensive, theory-guided survey of barriers and enablers to participation in breast cancer clinical trials is feasible, can lead to detailed knowledge about the issues related to participation in specific trials, and most importantly, can lead to insights about evidence-based ways to better support patient participation.

Background: Effective teamwork is critical for safe, high-quality care in the operating room (OR); however, teamwork interventions have not consistently resulted in the expected gains for patient safety or surgical culture. In order to optimize OR teamwork in a targeted and evidence-based manner, it is first necessary to conduct a comprehensive, theory-informed assessment of barriers and enablers from an interprofessional perspective., Methods: This qualitative study was informed by the Theoretical Domains Framework (TDF). Volunteer, purposive and snowball sampling were conducted primarily across four sites in Ontario, Canada and continued until saturation was reached. Interviews were recorded, transcribed, and de-identified. Directed content analysis was conducted in duplicate using the TDF as the initial coding framework. Codes were then refined whereby similar codes were grouped into larger categories of meaning within each TDF domain, resulting in a list of domain-specific barriers and enablers., Results: A total of 66 OR healthcare professionals participated in the study (19 Registered Nurses, two Registered Practical Nurses, 17 anaesthesiologists, 26 surgeons, two perfusionists). The most frequently identified teamwork enablers included people management, shared definition of teamwork, communication strategies, positive emotions, familiarity with team members, and alignment of teamwork with professional role. The most frequently identified teamwork barriers included others' personalities, gender, hierarchies, resource issues, lack of knowledge of best practices for teamwork, negative emotions, conflicting norms and perceptions across professions, being unfamiliar with team members, and on-call/night shifts., Conclusions: We identified key factors influencing OR teamwork from an interprofessional perspective using a theoretically informed and systematic approach. Our findings reveal important targets for future interventions and may ultimately increase their effectiveness. Specifically, achieving optimal teamwork in the OR may require a multi-level intervention that addresses individual, team and systems-level factors with particular attention to complex social and professional hierarchies., Competing Interests: The authors have declared that no competing interests exist.

Background: Clinical trial recruitment is a continuing challenge for medical researchers. Previous efforts to improve study recruitment have rarely been informed by theories of human decision making and behavior change. We investigate the trial recruitment strategies reported by study recruiters, guided by two influential theoretical frameworks: shared decision-making (SDM) and the Theoretical Domains Framework (TDF) in order to explore the utility of these frameworks in trial recruitment., Methods: We interviewed all nine active study recruiters from a multi-site, open-label pilot trial assessing the feasibility of a large-scale randomized trial. Recruiters were primarily nurses or master's-level research assistants with a range of 3 to 30 years of experience. The semi-structured interviews included questions about the typical recruitment encounter, questions concerning the main components of SDM (e.g. verifying understanding, directive vs. non-directive style), and questions investigating the barriers to and drivers of their recruitment activities, based on the TDF. We used directed content analysis to code quotations into TDF domains, followed by inductive thematic analysis to code quotations into sub-themes within domains and overarching themes across TDF domains. Responses to questions related to SDM were aggregated according to level of endorsement and informed the thematic analysis., Results: The analysis helped to identify 28 sub-themes across 11 domains. The sub-themes were organized into six overarching themes: coordinating between people, providing guidance to recruiters about challenges, providing resources to recruiters, optimizing study flow, guiding the recruitment decision, and emphasizing the benefits to participation. The SDM analysis revealed recruiters were able to view recruitment interactions as successful even when enrollment did not proceed, and most recruiters took a non-directive (i.e. providing patients with balanced information on available options) or mixed approach over a directive approach (i.e. focus on enrolling patient in study). Most of the core SDM constructs were frequently endorsed., Conclusions: Identified sub-themes can be linked to TDF domains for which effective behavior change interventions are known, yielding interventions that can be evaluated as to whether they improve recruitment. Despite having no formal training in shared decision-making, study recruiters reported practices consistent with many elements of SDM. The development of SDM training materials specific to trial recruitment could improve the informed decision-making process for patients.

Objectives: Despite clear evidence showing that many clinical trials fail or are delayed because of poor patient recruitment, there is surprisingly little empirically supported guidance for trialists seeking to optimize their trial recruitment strategies. We propose that the challenges of recruitment can be better understood and addressed by thinking of research participation as one or more behaviors, subject to the same forces as other human behaviors. In this article, we describe an adaptable, behavioral theory-driven approach for designing pretrial surveys of the barriers and drivers relevant to trial participation. Instead of proposing a single survey instrument intended to be used uniformly across many situations, we propose that tailored surveys be informed by a common comprehensive, theory-guided development approach that ensures all domains potentially guiding participation are considered., Study Design and Setting: We used the Theoretical Domains Framework (TDF), which organizes over 100 constructs known to be associated with behavior and behavior change into 14 domains that describe determinants of professional and patient health behaviors, to inform the development of tailored surveys about barriers to and drivers of clinical trial participation. After searching the literature for barriers and drivers to trial recruitment relevant to each of the TDF domains, we developed separate surveys for members of two national health charities (Canadian Breast Cancer Network, Huntington Society of Canada) to exemplify how the approach can be adapted across settings. We conducted think-aloud interviews with members of each group to maximize the clarity and usability of the surveys, elicited opinions about which barriers/drivers were relevant for each patient group, and identified additional barriers/drivers. Interviews proceeded iteratively with changes incorporated into subsequent interviews. Here, we describe our two target patient groups, as well as our process of modifying, adding, and deleting barrier/driver items for each group and across theoretical domains., Results: We interviewed 8 women with a history of breast cancer from the Canadian Breast Cancer Network (48-65 year old) and 11 Huntington Disease community members (9 women) from the Huntington Society of Canada (26-70 year old). After the iterative development interviews, the breast cancer group had identified 38 barriers/drivers thought relevant to their participation in clinical trials across 12 TDF domains. The Huntington group identified 47 items across 13 TDF domains., Conclusion: Our patient-focused and theory-guided approach was able to identify a more comprehensive range of barriers to and drivers of trial participation than existing published tools. Our approach is also more broadly adaptable than such tools, in that it uses a theoretical framework and in-depth piloting to generate a set of items tailored to each specific clinical area, rather than a single set of items intended to be applicable to all situations. This theory-guided approach also enables more specific recruitment strategies to be developed once domain-specific barriers are known, potentially optimizing participation for a given trial and helping build a cumulative evidence of barriers/drivers and strategies for addressing them., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Funded health research is being published in journals that many regard as "predatory", deceptive, and non-credible. We do not currently know whether funders provide guidance on how to select a journal in which to publish funded health research. Methods: We identified the largest 46 philanthropic, public, development assistance, public-private partnership, and multilateral funders of health research by expenditure, globally as well as four public funders from lower-middle income countries, from the list at https://healthresearchfunders.org. One of us identified guidance on disseminating funded research from each funders' website (August/September 2017), then extracted information about selecting journals, which was verified by another assessor. Discrepancies were resolved by discussion. Results were summarized descriptively. This research used publicly available information; we did not seek verification with funding bodies. Results: The majority (44/50) of sampled funders indicated funding health research. 38 (of 44, 86%) had publicly available information about disseminating funded research, typically called "policies" (29, 76%). Of these 38, 36 (95%) mentioned journal publication for dissemination of which 13 (36.11%) offer variable guidance on selecting a journal, all of which relate to the funder's open access mandate. Six funders (17%) outlined publisher requirements or features by which to select a journal. One funder linked to a document providing features of journals to look for (e.g. listed in the Directory of Open Access Journals) and to be wary of (e.g., no journal scope statement, uses direct and unsolicited marketing). Conclusions: Few funders provided guidance on how to select a journal in which to publish funded research. Funders have a duty to ensure that the research they fund is discoverable by others. This research is a benchmark for funder guidance on journal selection prior to the January 2021 implementation of Plan S (a global, funder-led initiative to ensure immediate, open access to funded, published research)., Competing Interests: Competing interests: When this work was undertaken JMG (Trials), LAS and DM (Systematic Reviews) were Editors-in-Chief for the open access published Biomed Central, for which they received stipends’; MJP was an (unpaid) editorial board member for PLOS Medicine and Journal of Clinical Epidemiology; and LS was an (unpaid) associate editor for BMC Systematic Reviews., (Copyright: © 2021 Shamseer L et al.)

Background: Audit and feedback (A&F) interventions are one of the most common approaches for implementing evidence-based practices. A key barrier to more effective A&F interventions is the lack of a theory-guided approach to the accumulation of evidence. Recent interviews with theory experts identified 313 theory-informed hypotheses, spread across 30 themes, about how to create more effective A&F interventions. In the current survey, we sought to elicit from stakeholders which hypotheses were most likely to advance the field if studied further., Methods: From the list of 313, three members of the research team identified 216 that were clear and distinguishable enough for prioritization. A web-based survey was then sent to 211 A&F intervention stakeholders asking them to choose up to 50 'priority' hypotheses following the header "A&F interventions will be more effective if…". Analyses included frequencies of endorsement of the individual hypotheses and themes into which they were grouped., Results: 68 of the 211 invited participants responded to the survey. Seven hypotheses were chosen by > 50% of respondents, including A&F interventions will be more effective… "if feedback is provided by a trusted source"; "if recipients are involved in the design/development of the feedback intervention"; "if recommendations related to the feedback are based on good quality evidence"; "if the behaviour is under the control of the recipient"; "if it addresses barriers and facilitators (drivers) to behaviour change"; "if it suggests clear action plans"; and "if target/goal/optimal rates are clear and explicit". The most endorsed theme was Recipient Priorities (four hypotheses were chosen 92 times as a 'priority' hypotheses)., Conclusions: This work determined a set of hypotheses thought by respondents to be to be most likely to advance the field through future A&F intervention research. This work can inform a coordinated research agenda that may more efficiently lead to more effective A&F interventions.

Background: Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need for informed consent. We reviewed a random sample of published cluster randomized trials involving only individual-level health care interventions to determine (a) the prevalence of reporting a rationale for the choice of cluster randomization; (b) the types of explicit, or if absent, apparent rationales for the use of cluster randomization; (c) the prevalence of reporting patient informed consent for study interventions; and (d) the types of justifications provided for waivers of consent. We considered cluster randomized trials for evaluating exclusively the individual-level health care interventions to focus on clinical trials where individual randomization is only theoretically possible and where there is a general expectation of informed consent., Methods: A random sample of 40 cluster randomized trials were identified by implementing a validated electronic search filter in two electronic databases (Ovid MEDLINE and Embase), with two reviewers independently extracting information from each trial. Inclusion criteria were the following: primary report of a cluster randomized trial, evaluating exclusively an individual-level health care intervention, published between 2007 and 2016, and conducted in Canada, the United States, European Union, Australia, or low- and middle-income country settings., Results: Twenty-five trials (62.5%, 95% confidence interval = 47.5%-77.5%) reported an explicit rationale for the use of cluster randomization. The most commonly reported rationales were those with logistical or administrative convenience (15 trials, 60%) and those that need to avoid contamination (13 trials, 52%); five trials (20%) were cited rationales related to the push for more pragmatic trials. Twenty-one trials (52.5%, 95% confidence interval = 37%-68%) reported written informed consent for the intervention, two (5%) reported verbal consent, and eight (20%) reported waivers of consent, while in nine trials (22.5%) consent was unclear or not mentioned. Reported justifications for waivers of consent included that study interventions were already used in clinical practice, patients were not randomized individually, and the need to facilitate the pragmatic nature of the trial. Only one trial reported an explicit and appropriate justification for waiver of consent based on minimum criteria in international research ethics guidelines, namely, infeasibility and minimal risk., Conclusion: Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards.

Background: Modeling studies to inform the design of complex health services interventions often involves elements that differ from the intervention's ultimate real-world use. These "hypothetical" elements include pilot participants, materials, and settings. Understanding the conditions under which studies with "hypothetical" elements can yield valid results would greatly help advance health services research. Our objectives are: 1) to conduct a systematic review of the literature to identify factors affecting the relationship between hypothetical decisions and real-world behaviours, and 2) to summarise and organize these factors into a preliminary framework., Methods: We conducted an electronic database search using PsycINFO and Medline on November 30th, 2015, updated March 7th, 2019. We also conducted a supplemental snowball search on December 9th 2015 and a reverse citation search using Scopus and Web of Science. Studies were eligible to be included in this review if they clearly addressed the consistency between some type of hypothetical decision and a corresponding real decision or behaviour. Two reviewers extracted data using a standardized data collection form developed through an iterative consensus-based process. We extracted basic study information and data about each study's research area, design, and research question. Quotations from the articles were extracted and summarized into standardized factor statements., Results: Of the 2444 articles that were screened, 68 articles were included in the review. The articles identified 27 factors that we grouped into 4 categories: decision maker factors, cognitive factors, task factors, and matching factors., Conclusions: We have summarized a large number of factors that may be relevant when considering whether hypothetical health services pilot work can be expected to yield results that are consistent with real-world behaviours. Our descriptive framework can serve as the basis for organizing future work exploring which factors are most relevant when seeking to develop complex health services interventions.

Background: There is a concern that the apparent effectiveness of interventions tested in clinical trials may not be an accurate reflection of their actual effectiveness in usual practice. Pragmatic randomized controlled trials (RCTs) are designed with the intent of addressing this discrepancy. While pragmatic RCTs may increase the relevance of research findings to practice they may also raise new ethical concerns (even while reducing others). To explore this question, we interviewed key stakeholders with the aim of identifying potential ethical challenges in the design and conduct of pragmatic RCTs with a view to developing future guidance on these issues., Methods: Interviews were conducted with clinical investigators, methodologists, patient partners, ethicists, and other knowledge users (e.g., regulators). Interviews covered experiences with pragmatic RCTs, ethical issues relevant to pragmatic RCTs, and perspectives on the appropriate oversight of pragmatic RCTs. Interviews were coded inductively by two coders. Interim and final analyses were presented to the broader team for comment and discussion before the analytic framework was finalized., Results: We conducted 45 interviews between April and September 2018. Interviewees represented a range of disciplines and jurisdictions as well as varying content expertise. Issues of importance in pragmatic RCTs were (1) identification of relevant risks from trial participation and determination of what constitutes minimal risk; (2) determining when alterations to traditional informed consent approaches are appropriate; (3) the distinction between research, quality improvement, and practice; (4) the potential for broader populations to be affected by the trial and what protections they might be owed; (5) the broader range of trial stakeholders in pragmatic RCTs, and determining their roles and responsibilities; and (6) determining what constitutes "usual care" and implications for trial reporting., Conclusions: Our findings suggest both the need to discuss familiar ethical topics in new ways and that there are new ethical issues in pragmatic RCTs that need greater attention. Addressing the highlighted issues and developing guidance will require multidisciplinary input, including patient and community members, within a broader and more comprehensive analysis that extends beyond consent and attends to the identified considerations relating to risk and stakeholder roles and responsibilities.

Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. We undertook semi-structured interviews with parents ( n = 32), healthcare professionals ( n = 19) and policy decision makers ( n = 17) in two Canadian provinces. Conceptions of consent-related terms revolved around seven factors within two broad domains, decision-making and information attainment . Decision-making comprised: parent decision authority; voluntariness; parent engagement with decision-making; and the process of enacting choice. Information ascertainment comprised: professional responsibilities (including disclosure of information and time to review); parent responsibilities; and the need for discussion and understanding prior to a decision. Our findings indicate that consent-related terms are variously understood, with substantive implications for practice. We suggest that consent procedures should be explained descriptively, regardless of approach, so there are clear indications of what is expected of parents and healthcare professionals. Support systems are required both to meet the educational needs of parents and families and to support healthcare professionals in delivering information in a manner in keeping with parent needs.

Background: Caregivers of children with health problems (CHPs; usually mothers) experience more physical and psychological health problems than those of children without health problems (non-CHPs). Primarily cross-sectional and survey-driven, this literature has not yet explored whether these health differences existed before the birth of the CHPs, or are exacerbated postbirth., Methods: Using linked administrative health data on all mother-child dyads for children born in the year 2000 in British Columbia, Canada, we examined maternal health before, during, and after the birth of CHPs, and compared it between mothers of CHPs and non-CHPs with piecewise growth curve modeling., Results: Compared with mothers of non-CHPs, mothers of CHPs had more physician visits (8.09 vs. 11.07), more medication types (1.81 vs. 2.60), and were more likely to be diagnosed with selected health conditions (30.9% vs. 42.5%) 4 years before the birth of the child. Over the 7-year postbirth period, the health of the 2 groups of mothers further diverged: while mothers of CHPs showed increases on physician visits and types of medication, mothers of non-CHPs did not experience any changes in physician visits and had less steep increases for types of medication., Conclusions: Health issues associated with having a child with a health problem may begin well before the birth of the child, but also appear to be exacerbated postbirth. The health challenges of caregivers of CHPs may be multifactorial, involving both preexisting conditions and the stresses associated with caring for a child with health problems.

Background: Audit and feedback (A&F) is a common quality improvement strategy with highly variable effects on patient care. It is unclear how A&F effectiveness can be maximised. Since the core mechanism of action of A&F depends on drawing attention to a discrepancy between actual and desired performance, we aimed to understand current and best practices in the choice of performance comparator., Methods: We described current choices for performance comparators by conducting a secondary review of randomised trials of A&F interventions and identifying the associated mechanisms that might have implications for effective A&F by reviewing theories and empirical studies from a recent qualitative evidence synthesis., Results: We found across 146 trials that feedback recipients' performance was most frequently compared against the performance of others (benchmarks; 60.3%). Other comparators included recipients' own performance over time (trends; 9.6%) and target standards (explicit targets; 11.0%), and 13% of trials used a combination of these options. In studies featuring benchmarks, 42% compared against mean performance. Eight (5.5%) trials provided a rationale for using a specific comparator. We distilled mechanisms of each comparator from 12 behavioural theories, 5 randomised trials, and 42 qualitative A&F studies., Conclusion: Clinical performance comparators in published literature were poorly informed by theory and did not explicitly account for mechanisms reported in qualitative studies. Based on our review, we argue that there is considerable opportunity to improve the design of performance comparators by (1) providing tailored comparisons rather than benchmarking everyone against the mean, (2) limiting the amount of comparators being displayed while providing more comparative information upon request to balance the feedback's credibility and actionability, (3) providing performance trends but not trends alone, and (4) encouraging feedback recipients to set personal, explicit targets guided by relevant information.

Introduction: Caregivers of children with health problems experience poorer health than the caregivers of healthy children. To date, population-based studies on this issue have primarily used survey data., Objectives: We demonstrate that administrative health data may be used to study these issues, and explore how non-categorical indicators of child health in administrative data can enable population-level study of caregiver health., Methods: Dyads from Population Data British Columbia (BC) databases, encompassing nearly all mothers in BC with children aged 6-10 years in 2006, were grouped using a non-categorical definition based on diagnoses and service use. Regression models examined whether four maternal health outcomes varied according to indicators of child health., Results: 162,847 mother-child dyads were grouped according to the following indicators: Child High Service Use (18%) vs. Not (82%), Diagnosis of Major and/or Chronic Condition (12%) vs. Not (88%), and Both High Service Use and Diagnosis (5%) vs. Neither (75%). For all maternal health and service use outcomes (number of physician visits, chronic condition, mood or anxiety disorder, hospitalization), differences were demonstrated by child health indicators., Conclusions: Mothers of children with health problems had poorer health themselves, as indicated by administrative data groupings. This work not only demonstrates the research potential of using routinely collected health administrative data to study caregiver and child health, but also the importance of addressing maternal health when treating children with health problems., Competing Interests: Statement on conflicts of interest: The authors declare they have no conflict of interest.

Background: Using linked administrative health data, this study compared the health and healthcare service utilization between mothers of children with and without neurodevelopmental disabilities (NDD), before, during, and after the birth of a child., Methods: The population (N = 25,388) was based on a cohort of children born in 2000 and who were, along with their mothers, continuously registered with the British Columbia's universal health insurance program between 2000 and 2007., Results: Compared to mothers of children without NDD, mothers of children with NDD were more likely to have chronic conditions and higher service utilization before child birth. Mothers of children with NDD showed a smaller increase in physician visits in the year before birth but a greater increase in different prescription drugs in the year after birth. There was no further divergence (or convergence) in health and service utilization between the groups in the 7-year period post-birth., Conclusions: Differences in health and healthcare service utilization between mothers of children with and without NDD existed before the birth of the child and did not diverge in the 7 years post-birth. Replication of these findings is warranted as well as follow-up analyses examining longer term outcomes for mothers beyond 7 years post-birth., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Family history (FH) is a risk factor for many conditions in pediatric practice. There is no standard of care regarding FH taking, and only a few published studies about current practice., Objectives: To explore in depth pediatricians' perceptions, attitudes, beliefs, and practices regarding FH taking., Methods: The Theoretical Domains Framework (TDF) was used to develop a comprehensive interview scheme. Semi-structured interviews were conducted with community pediatricians. Interviews were audio-recorded, transcribed, and analyzed using a thematic approach and the constant comparison method., Results: Eleven pediatricians were interviewed. FH was found to be a firmly embedded, complex, and important aspect of pediatric practice. Participants described FH as part of regular holistic care. FH and social history were linked and often appeared to be part of the same concept to participants. FH was used for a range of purposes. In addition to risk assessment, FH information helped clarify diagnosis and select medication, tailor overall patient management based on family circumstance, and provide psychosocial support for parents. Participants expressed confidence in their FH skills and reported tailoring their approach with experience. Most were not concerned about formal evidence for FH and would not change their practice except for "good reason.", Conclusions: The use of the TDF helped ensure a comprehensive approach to FH taking in pediatric practice. The findings suggest that FH taking in this setting is a complex activity, embedded in routine care. Efforts to make FH taking more systematic may founder if they fail to take into account pediatricians' attitudes, perspectives, and practices., (© 2019 S. Karger AG, Basel.)

Background: There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic health records, centralized research ethics review, and novel trial designs, combined with support and resources from governments worldwide for patient-centered research, have created an unprecedented opportunity to advance the conduct of pragmatic trials, which can ultimately improve patient health and health system outcomes. Such trials raise ethical issues that have not yet been fully addressed, with existing literature concentrating on regulations in specific jurisdictions rather than arguments grounded in ethical principles. Proposed solutions (e.g. using different regulations in "learning healthcare systems") are speculative with no guarantee of improvement over existing oversight procedures. Most importantly, the literature does not reflect a broad vision of protecting the core liberty and welfare interests of research participants. Novel ethical guidance is required. We have assembled a team of ethicists, trialists, methodologists, social scientists, knowledge users, and community members with the goal of developing guidance for the ethical design and conduct of pragmatic trials., Methods: Our project will combine empirical and conceptual work and a consensus development process. Empirical work will: (1) identify a comprehensive list of ethical issues through interviews with a small group of key informants (e.g. trialists, ethicists, chairs of research ethics committees); (2) document current practices by reviewing a random sample of pragmatic trials and surveying authors; (3) elicit views of chairs of research ethics committees through surveys in Canada, UK, USA, France, and Australia; and (4) elicit views and experiences of community members and health system leaders through focus groups and surveys. Conceptual work will consist of an ethical analysis of identified issues and the development of new ethical solutions, outlining principles, policy options, and rationales. The consensus development process will involve an independent expert panel to develop a final guidance document., Discussion: Planned output includes manuscripts, educational materials, and tailored guidance documents to inform and support researchers, research ethics committees, journal editors, regulators, and funders in the ethical design and conduct of pragmatic trials.

Background: Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature., Methods: We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis., Results: Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low., Conclusion: The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs.

Objective: Informed consent documents are often poorly understood by research participants. In critical care, issues such as time pressure, patient capacity, and surrogate decision making complicate the consent process further. Recommendations exist for addressing critical care-specific consent issues; we examined how well existing practice implements these recommendations., Design: We conducted a systematic search of the literature for recommendations specific to critical care informed consent and rated existing informed consent documents on their implementation of 1) 18 of these critical care recommendations and 2) 36 previously developed general informed consent recommendations. Four hundred twelve registered critical care trials were identified and a request sent to the principal investigators for an example of the informed consent document associated with the trial. Each consent document was rated on both set of recommendations., Setting: We evaluated informed consent documents for trials conducted in English or French registered with clinicaltrials.gov., Patients: Not applicable., Interventions: Not applicable., Measurements and Main Results: Independent coders rated implementation of each recommendation on a four-point scale. Of 412 requests, 137 informed consent documents were returned, for a response rate of 34.1%. Of these, 86 met inclusion criteria and were assessed. Overall agreement between raters was 90.6% (weighted κ = 0.79; 0.77-0.81). Implementation of the 18 critical care recommendations was highly variable, ranging between 2% and 96.5%., Conclusions: Critical care studies often do not provide the information recommended for those providing consent for research. These clear recommendations provide testable hypotheses about how to improve the consent process for patients and family members considering trial participation in the critical care setting.

Objectives: Nurses and respiratory therapists are seldom allowed to use automated external defibrillators (AED) during in-hospital cardiac arrest. This can result in significant time delays before defibrillation occurs and lower survival for cardiac arrest victims. We sought to identify barriers and facilitators to AED use by nurses and respiratory therapists., Methods: We conducted semi-structured qualitative interviews with a purposeful sample of nurses and respiratory therapists. We developed the interview guide based on the constructs of the theory of planned behaviour, which elicits salient attitudes, social influences, and control beliefs potentially influencing the intent to use an AED. Interviews were recorded, transcribed verbatim, and analysed until achieving data saturation. Two independent reviewers performed inductive analyses to identify emerging categories and themes, and ranked them by frequency of the number of participants stating the topic., Results: Demographics for the 24 interviewees include mean age 40.5, 79.2% female, 87.5% performed cardiopulmonary resuscitation (CPR), 29.2% defibrillated a patient. Identified attitudes pertained to the timeliness of defibrillation, patient survival, simplicity of AED use, accuracy of rhythm recognition, and harm to self or others. Social influences consisted of physician and hospital administration support of AED use. Control beliefs included training on AED use, policy allowing AED use, familiarity with AED, and task burden during resuscitation., Conclusions: Most nurses and respiratory therapists intended to use an AED if permitted to do so by a medical directive. Successful implementation would require educational initiatives focusing on safety and efficacy of AEDs, support from physicians and hospital administrators, and additional training on AED use.

Aim: The aim of this study was to identify children with neurodevelopmental disorders and disabilities (NDD/D) and compare their healthcare service utilization to children without NDD/D using provincial linked administrative data., Method: The sample included children aged 6 to 10 years (n=183 041), who were registered with the British Columbia Medical Services Plan. Diagnostic information was used for the identification and classification of NDD/D in six functional domains. Healthcare service utilization included outcomes based on physician claims, prescription medication use, and hospitalization., Results: Overall, 8.3% of children were identified with NDD/D. Children with NDD/D had higher healthcare service utilization rates than those without NDD/D. Effect sizes were: very large for the number of days a prescription medication was dispensed; large for the number of prescriptions; medium for the number of physician visits, different specialists visited, number of different prescription medications, and ever hospitalized; and small for the number of laboratory visits, X-ray visits, and number of days hospitalized., Interpretation: The findings have policy implications for service and resource planning. Given the high use of psychostimulants, specialized services for both NDD/D and psychiatric conditions may be the most needed services for children with NDD/D. Future studies may examine patterns of physician behaviours and costs attributable to healthcare service utilization for children with NDD/D., What This Paper Adds: Children with neurodevelopmental disorders and disabilities (NDD/D) have higher healthcare service utilization than those without. Based on provincial population-based linked administrative health data, a sizeable number of children are living with NDD/D. Given the high use of psychostimulants, specialized services for children with both NDD/D and psychiatric conditions may be the most needed services for children with NDD/D., (© 2017 Mac Keith Press.)